“Intravitreal fluocinolone acetonide implant: a prospective, pilot study on patients with chronic diabetic macular edema” 

OBJECTIVES To analyze the clinical efficacy and safety profile of intravitreal 0.19 mg fluocinolone acetonide (FAc) implant (Iluvien®) in patients with chronic/ refractory diabetic macular edema (DME) SUBJECTS/METHODS This a prospective, cross-sectional pilot study enrolling patients with chronic DME, previously treated with intravitreal anti-vascular endothelial growth factors (VEGF) agents and/or intravitreal corticosteroids. The primary endpoints were the modifications in best-corrected visual acuity (BCVA) and central macular thickness (CMT) during the follow-up. Secondary endpoints were recurrence rate, the presence of systemic and/or ocular adverse events (AEs), including changes in intraocular pressure (IOP). RESULTS Fourteen eyes of 11 patients were enrolled in this study. Average follow-up period was 18.7 months ± 8.2. Baseline BCVA improved from 59.6 letters to 61.1 letters after 1 month (p=0.994), 63.1 letters after 3 months (p=0.819), 63.7 letters after 6 months (p=0.635), 68.7 letters after 12 months (p=0.07) and 67.7 letters after 18 months (p=0.505). Baseline CMT significantly decreased from 378 µm before Fac treatment to 336 µm after 1 month (p= 0.034), 320 µm after 3 months (p= 0.015), 329 µm after 6 months (p= 0.05), 314 µm after 12 months (p= 0.0025) and 271 µm after 18 months (p= 0.001). Eight eyes (57.1%) needed to be re-injected with anti-VEGF drugs within 12 months and only one (7.1%) was retreated with DEX implant. No systemic and/ocular AES were reported, including significant variations in IOP. CONCLUSIONS FAc implant can be considered an effective and safe treatment option in patients with chronic/refractory DME.